ILLUMENATE Pivotal Post-Approval Study (PAS)

Spectranetics Corporation300 enrolled

Overview

The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB. Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Peripheral Artery Disease

Interventions

Stellarex 0.035" OTW Drug-coated Angioplasty BalloonDEVICE

The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.

EverCross™ 0.035 PTA Balloon CatheterDEVICE

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E Study subjects must fulfill the following clinical criteria: 1. Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery. 2. Greater than or equal to 18 years of age. 3. Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows. 4. Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment). 5. Life expectancy \>1 year. 6. Rutherford-Becker classification of 2, 3 or 4. Study Subjects must fulfill the following angiographic criteria: 7. De novo or restenotic lesion (except for in-stent restenotic lesion) \>70% within the SFA and/or popliteal artery in a single limb. 8. Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm. 9. Lesion is treatable by no more than two (2) study devices. 10. Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion. 11. Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation). 12. Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis \<30% without death or major vascular complication. 13. Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted. Exclusion Criteria - Subject with any of the following clinical criteria should be excluded: 1. Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation. 2. Known aortic aneurysm(s) \> 5 cm. 3. Contraindication to dual anti-platelet therapy. 4. Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated. 5. Current participation in an investigational drug or another device study. 6. History of hemorrhagic stroke within 3 months. 7. Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment). 8. Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion. 9. Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter. 10. Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session. 11. Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure). Subject with any of the following angiographic criteria should be excluded: 12. Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure. 13. No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured. 14. Known inadequate distal outflow. 15. Acute or sub-acute thrombus in the target vessel. 16. Aneurysmal target vessel. 17. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel. 18. Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment). 19. Presence of concentric calcification that precludes PTA pre-dilation. 20. Prior stent placement in the target vessel. 21. Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.

Locations (41)

Outcomes

Primary Outcomes

Number of Participants With Target Vessel Patency at 24 Months Post-procedure

Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

Time frame: 24 months post-procedure

Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure

The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).

Time frame: 24 months post-procedure

Secondary Outcomes

Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame: 24 months post-procedure

Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame: 36 months post-procedure

Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Data from ClinicalTrials.gov

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Yuma Regional Medical Center

Yuma, Arizona, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Good Samaritan Hospital - Los Angeles

Los Angeles, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Cardiovascular Research of North Florida

Gainesville, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Coastal Vascular and Interventional

Pensacola, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

...and 31 more locations

Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame: 48 months post-procedure

Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)

Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Time frame: 60 months post-procedure

Rate of Clinically-driven Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Time frame: 24 months post-procedure

Rate of Clinically-driven Target Lesion Revascularization

Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Time frame: 36 months post-procedure

Rate of Clinically-driven Target Lesion Revascularization

Time frame: 48 months post-procedure

Rate of Clinically-driven Target Lesion Revascularization

Time frame: 60 months post-procedure

Rate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame: 24 months post-procedure

Rate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame: 36 months post-procedure

Rate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame: 48 months post-procedure

Rate of Target Lesion Revascularization

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Time frame: 60 months post-procedure

Rate of Clinically-driven Target Vessel Revascularization

Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Time frame: 24 months post-procedure

Rate of Clinically-driven Target Vessel Revascularization

Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Time frame: 36 months post-procedure

Rate of Clinically-driven Target Vessel Revascularization

Time frame: 48 months post-procedure

Rate of Clinically-driven Target Vessel Revascularization

Time frame: 60 months post-procedure

Rate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame: 24 months post-procedure

Rate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame: 36 months post-procedure

Rate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame: 48 months post-procedure

Rate of Target Limb Major Amputation

Number of subjects in which a major amputation occurred in the target limb

Time frame: 60 months post-procedure

Mortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame: 24 months post-procedure

Mortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame: 36 months post-procedure

Mortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame: 48 months post-procedure

Mortality Rate

Number of subject who have died during the post-procedure follow up period

Time frame: 60 months post-procedure

Rate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame: 24 months post-procedure

Rate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame: 36 months post-procedure

Rate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame: 48 months post-procedure

Rate of Occurrence of Arterial Thrombosis of the Treated Segment

Rate of occurrence of arterial thrombosis of the treated segment

Time frame: 60 months post-procedure

Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR

Time frame: 24 months post-procedure

Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR

Time frame: 36 months post-procedure

Change in Ankle-brachial Index (ABI) From Pre-procedure

The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.

Time frame: 24 months post-procedure

Change in Ankle-brachial Index (ABI) From Pre-procedure

Time frame: 36 months post-procedure

Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure

A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication

Time frame: 24 months post-procedure

Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure

Time frame: 36 months post-procedure

Change in Walking Distance From Pre-procedure

Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.

Time frame: 24 months post-procedure

Change in Walking Distance From Pre-procedure

Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.

Time frame: 36 months post-procedure

Change in Rutherford-Becker Classification From Pre-procedure

Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.

Time frame: 24 months post-procedure

Change in Rutherford-Becker Classification From Pre-procedure

Time frame: 36 months post-procedure

Change in EQ-5D Index From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.

Time frame: 24 months post-procedure

Change in EQ-5D Index From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.

Time frame: 36 months post-procedure

Change in EQ-5D VAS From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion

Time frame: 24 months post procedure

Change in EQ-5D VAS From Pre-procedure

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion

Time frame: 36 month post procedure